ModeunBio Advances Global Clinical Trials for COVID-19 Therapeutic Candidates

[Asia Economy Reporter Hyungsoo Park] Modeun Bio (CEO Jinha Lee), a natural product-based new drug development company, announced on the 7th that it has signed a memorandum of understanding (MOU) with the European clinical trial contract research organization (CRO) OPIS for clinical trials of a candidate treatment for COVID-19.

Modeun Bio is researching and developing 'MDB-601a-NM' as a candidate treatment for COVID-19. A representative from Modeun Bio explained, "In our own conducted tests, MDB-601a-NM showed more than 50 times the efficacy compared to the use of Nafamostat alone," adding, "Drug release tests also yielded results improving the short half-life, which is a drawback of Nafamostat."

To proceed with clinical trials in Europe, Modeun Bio signed an MOU with the local CRO OPIS and is also negotiating production by signing a confidentiality disclosure agreement (CDA) with Lonza, a contract manufacturing organization (CMO) based in Switzerland.

Domestic clinical trials are also underway. A Modeun Bio representative stated, "Our candidate substance MDB-601a-NM is an oral drug that can be stored at room temperature, ensuring safety and stability," and added, "Since there is sufficient possibility for fast-track approval in domestic clinical trials, we are in discussions with CROs."

The core of the new drug candidate MDB-601a-NM is its drug delivery system (DDS). Modeun Bio’s DDS uses a green synthesis method based on edible solvents without organic solvents or chemical reagents, ensuring safety and stability.

The raw material for the drug delivery agent, MDB-601, is already used as a food ingredient and pharmaceutical. MDB-601a, which is particle-processed using the green method, is predicted to have secured safety. The antiviral effects of the raw material have also been confirmed through numerous studies.

Nafamostat is already a listed drug used for pancreatitis treatment and is being researched by many domestic and international pharmaceutical companies because it not only inhibits COVID-19 virus entry but also suppresses the activation of NF-kB, which plays a key role in the cytokine storm.

A Modeun Bio representative explained, "The drug delivery agent MDB-601a itself has strong acid resistance, enabling oral drug research and development," and added, "We are in discussions with domestic and local clinical CROs regarding simultaneous Phase 1 and 2 clinical trials."

Jinha Lee, CEO of Modeun Bio, said, "As a latecomer, we plan to accelerate the research and development period as much as possible to develop and launch the world’s first oral treatment for COVID-19."

This content was produced with the assistance of AI translation services.